Clinical Supply Chain Manager

We are seeking an experienced and highly organized Clinical Supply Manager to join our growing CMC team. As a Clinical Supply Manager, you will be responsible for managing the clinical supply chain for clincal-stage programs and ensuring the timely and efficient delivery of clinical trial materials. This role requires a deep understanding of clinical trial supply management, strong project management skills, and the ability to collaborate effectively with cross-functional teams. The ideal candidate will have a proven track record of successfully managing clinical supply activities within the pharmaceutical or biotechnology industry.

• Develop and execute comprehensive clinical supply strategies and plans for multiple clinical programs, ensuring alignment with study protocols, timelines, and region-specific regulatory requirements
• Manage the end-to-end clinical supply chain, including forecasting, planning, packaging, labeling, distribution, and inventory management including necessary ancillary materials and equipment
• Collaborate with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) to ensure seamless coordination and execution of clinical supply activities
• Establish and maintain relationships with external vendors and suppliers, negotiating contracts, managing performance, and ensuring adherence to quality standards
• Monitor and manage clinical trial material inventory levels, track usage, shelf life dates and disposition of materials across multiple global clinical studies
• Oversee the labeling and packaging of clinical trial materials, ensuring compliance with relevant regulations and guidelines
• Implement and maintain robust systems and processes for tracking and documenting clinical supply activities, including batch records, shipping records, and inventory management systems
• Monitor and analyze clinical supply chain performance metrics, identify areas for improvement, and implement corrective actions as needed
• Provide regular inventory status updates, guidance and support to project teams regarding clinical supply chain cons

• Bachelor's degree in a scientific or related field
• Minimum of 5+ years of experience in clinical supply chain management within the pharmaceutical or biotechnology industry
• Strong understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and relevant regulatory guidelines (e.g., ICH, FDA, EMA)
• Experience with cold chain management for global distribution of clinical products
• Demonstrated experience in end-to-end clinical supply chain management, including forecasting, planning, packaging, labeling, distribution, and inventory management
• Excellent project management skills with the ability to manage multiple projects simultaneously and prioritize tasks with team and management input
• Ability to proactively identify and address supply chain issues
• Proficiency in specification and use of interactive response technology (IRT) systems
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners
• Attention to detail and a commitment to delivering high-quality work within established timelines
• Flexibility and adaptability to work in a fast-paced and evolving environment